The First FDA Warning Letter on AI: What It Means for Your Quality System
The FDA issued its first AI-related Warning Letter. Learn what it means for your QMS, validation requirements, and how to keep your quality systems inspection-ready.
Instructor
Dr. Ginette Collazo
Industrial-Organizational Psychologist & GMP Human Performance Expert
What You'll Learn
About the event
About this event
Artificial Intelligence (AI) is rapidly transforming regulated industries, from automated quality reviews and predictive maintenance to complaint handling and CAPA management. However, with innovation comes regulatory scrutiny. The FDA's first Warning Letter involving the use of AI has become a defining moment for GMP-regulated organizations, signaling that regulators expect AI-enabled processes to be validated, controlled, monitored, and fully integrated into the organization's Quality Management System (QMS).
This webinar explores the implications of FDA enforcement actions related to AI and explains what organizations must do to maintain compliance while adopting advanced technologies. Participants will gain insight into how FDA expectations for data integrity, validation, risk management, change control, and oversight apply to AI-driven systems and decision-making processes.
The session will also discuss practical approaches for integrating AI into existing quality systems without compromising regulatory compliance. From supplier qualification and algorithm validation to human oversight and deviation management, attendees will learn how to proactively prepare for FDA inspections and avoid compliance gaps.
By understanding the regulatory landscape surrounding AI, organizations can confidently leverage innovation while maintaining patient safety, product quality, and operational excellence.
WHY YOU SHOULD ATTEND
AI adoption in regulated industries is accelerating, but many organizations remain unclear about FDA expectations regarding validation, oversight, documentation, and risk management. The FDA's first AI-related Warning Letter demonstrates that regulators are closely evaluating how companies implement and control AI-enabled systems within their quality operations. This session provides practical guidance for understanding the compliance risks associated with AI and the steps organizations should take to ensure their quality systems remain inspection-ready.
SESSION HIGHLIGHTS
- Regulatory Clarity: Understand the significance of the FDA's first AI-related Warning Letter and its impact on GMP-regulated industries.
- Compliance Readiness: Learn how AI systems should be validated, monitored, and controlled within a compliant QMS.
- Risk-Based Strategies: Discover approaches for managing AI-related risks including bias, data integrity, cybersecurity, and change management.
- Practical Implementation: Gain actionable recommendations for integrating AI into quality operations while maintaining regulatory oversight.
By attending this training, participants will gain a clearer understanding of how to responsibly implement AI technologies while meeting FDA expectations and strengthening quality assurance practices.
Code: FDB1305
Curriculum
Requirements
- Working in FDA-regulated industries (pharma, biotech, medical device)
- Familiarity with GMP regulations and quality systems
- Applicable to quality assurance, regulatory affairs, validation, and operations professionals
Who Should Attend
Quality Assurance, Regulatory Affairs, Validation and Computer System Validation (CSV) Specialists, Compliance Officers, Manufacturing and Operations, IT and Digital Transformation Managers, CAPA and Deviation Management Teams, Data Integrity Specialists, Risk Management Professionals, Internal Auditors and Inspection Readiness Teams, and Executive Leadership evaluating AI adoption strategies.
Areas Covered
Meet Your Instructor
Dr. Ginette Collazo
Industrial-Organizational Psychologist & GMP Human Performance Expert
Dr. Ginette Collazo brings 20+ years of experience in Industrial-Organizational Psychology specializing in GMP-regulated industries and human performance systems. She is an internationally recognized expert in quality systems, root cause analysis, compliance excellence, and operational performance. As Founder and CEO of Human Error Solutions—recognized by Manufacturing Outlook magazine in 2023 as one of the top industrial service providers—she leads a globally recognized consulting and training organization supporting regulated industries. Dr. Collazo is an experienced speaker and educator on GMP compliance, human performance, AI governance, and quality culture, and has been featured in Manufacturing Outlook, ABC, NBC, Fox, and CBS for her contributions to manufacturing excellence and compliance innovation. She is also the host of The Power of Why Podcast, exploring workplace behavior, leadership, critical thinking, and emerging technologies.
Event Details
Format
Recorded Webinar
Duration
1 hour
Certificate
Included
Access
Lifetime
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